Trial Information

Summary: Capecitabine (Xeloda) With Or Without GW572016 For Women With Refractory Advanced Or Metastatic Breast Cancer.

The purpose of this study is to compare the efficacy and safety of an oral dual tyrosine kinase inhibitor in combination with capecitabine versus capecitabine alone in refractory advanced or metastatic breast cancer.

Inclusion Criteria:

• Signed Consent
• Advanced or Metastic Breast Cancer
• Documented ErbB2 overexpression
• Documented disease progression
• Prior treatments must have included: an anthracycline, and taxane containing regimens concurrently or sequentially.
• Prior treatment with Herceptin alone or in combination.
• If hormone positive (ER/PR), must have received hormonal therapy.
• Tumor tissue available for testing
• Females at least 18 years of age
• Adequate hematology, kidney and liver function
• Adequate bone marrow function

Exclusion Criteria:

• Pregnant or lactating
• Serious medical or psychiatric disorders that would interfere with the patient's safety or informed consent.
• Severe cardiac disease or cardiac disease requiring a device
• Active infection
• Unresolved toxicities from prior therapies.
• Brain metastases

Healthy Volunteers: no
Gender: Female
Minimum Age: 18 Years
Maximum Age: N/A

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Trial listings updated: June 1, 2008 at 5:43:58 AM